Recommendations for Medicinal Product Distributors on Sales Practices – AEMPS Guidelines

Purpose and Scope

AEMPS issued these recommendations to guide wholesale distributors of human medicinal products in Spain on best practices for sales and commercial activities. The guidance aims to ensure compliance with Royal Decree 782/2013, Good Distribution Practice (GDP) principles, and the Falsified Medicines Directive (2011/62/EU), while preventing unethical practices, supply chain risks, and potential diversion of medicines. It applies to all authorised distributors engaging in promotion, negotiation, and supply of medicines. Recomendaciones a distribuidores de medicamentos: pautas de ventas - AEMPS

Key Recommendations for Ethical Sales

• Customer Legitimacy Verification: Always confirm that customers (pharmacies, hospitals, other wholesalers) are authorised entities using the AEMPS public catalogue before any transaction.
• No Aggressive or Misleading Promotion: Avoid promotional practices that pressure customers, exaggerate benefits, or provide misleading information about products, prices, or availability.
• Transparent Pricing and Conditions: Provide clear, accurate information on prices, discounts, payment terms, and delivery conditions; avoid discriminatory or abusive pricing practices.
• Prohibition of Inducements: Do not offer gifts, benefits, or incentives that could influence purchasing decisions beyond normal commercial discounts.
• Documentation of Transactions: Maintain complete, auditable records of all offers, negotiations, orders, and deliveries, including date, product details, quantities, and customer identification.

Supply Chain Integrity Measures

• Risk-Based Controls: Implement enhanced due diligence for high-risk customers (new clients, large volumes, unusual patterns) to prevent diversion to illicit channels.
• Falsified Medicines Prevention: Verify authenticity of incoming supplies and report any suspicions immediately to AEMPS; ensure safety features (unique identifiers) are properly handled.
• Responsible Person Oversight: The Responsible Person must supervise commercial activities to ensure they align with GDP and regulatory obligations.
• Training and Internal Procedures: Establish written SOPs for sales practices and provide regular training to commercial staff on ethical standards and compliance.

Prohibited Practices

• Offering medicines without proper authorisation or outside authorised scope.
• Conditioning supply on unrelated purchases or exclusive agreements that restrict competition.
• Providing false or incomplete information to customers.
• Engaging in sales that could facilitate parallel export without proper notification.

Compliance and Enforcement

Distributors are encouraged to integrate these recommendations into their quality management system and conduct internal audits. Non-compliance may lead to inspection findings, improvement notices, or sanctions by AEMPS. The document serves as a practical tool to support ethical conduct and maintain trust in the pharmaceutical distribution chain.

These AEMPS guidelines reinforce responsible sales behaviour among distributors, contributing to patient safety, supply chain security, and fair market practices in Spain. The full recommendations document, including detailed examples and checklists, is available for download on the AEMPS website. Recomendaciones a distribuidores de medicamentos: pautas de ventas - AEMPS